Certificate in ISO 13485: Essential Skills
-- ViewingNowThe Certificate in ISO 13485: Essential Skills course is a professional development program designed to equip learners with the necessary skills to implement and manage quality management systems in the medical device industry. This course is of utmost importance due to the increasing demand for compliance with ISO 13485 standards, which are essential for organizations involved in the design, production, installation, and servicing of medical devices.
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โข Understanding ISO 13485: This unit will cover the basics of ISO 13485, its purpose, and how it applies to medical device quality management systems. โข QMS Documentation: This unit will cover the documentation requirements for a QMS under ISO 13485, including the creation and maintenance of quality manuals, procedures, work instructions, and records. โข Management Responsibility: This unit will cover the responsibilities of top management under ISO 13485, including the establishment of quality policy and objectives, management review, and resource management. โข Resource Management: This unit will cover the resource management requirements of ISO 13485, including human resources, infrastructure, and the work environment. โข Product Realization: This unit will cover the product realization requirements of ISO 13485, including design and development, purchasing, production, and installation. โข Measurement, Analysis, and Improvement: This unit will cover the measurement, analysis, and improvement requirements of ISO 13485, including monitoring and measurement, internal audits, and corrective and preventive action. โข Medical Device Regulations: This unit will cover the relevant medical device regulations that apply to a QMS under ISO 13485. โข Risk Management: This unit will cover the risk management requirements of ISO 13485 and how to integrate risk management into a QMS. โข Supplier Management: This unit will cover the supplier management requirements of ISO 13485, including the selection, evaluation, and monitoring of suppliers. โข Training and Competence: This unit will cover the training and competence requirements of ISO 13485, including the identification and documentation of training needs, training records, and competence assessment.
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